RECRUITING

Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

Talk to us

Conditions

Hidradenitis Suppurativaskin diseaseruxolitinb cream

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Official Title

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Quick Facts

Study Start:2025-06-11
Study Completion:2027-07-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06958211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of HS for at least 6 months prior to screening visit.
  2. * Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:
  3. * A total AN count of at least 4, with no draining tunnels AND
  4. * Affecting at least 2 distinct anatomical areas
  5. * Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
  6. * Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.
  7. * Further inclusion criteria apply.
  1. * Body surface areas to be treated exceed 20% BSA at screening or baseline
  2. * Presence of draining tunnels at screening or baseline.
  3. * Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
  4. * Laboratory values outside of the protocol-defined criteria.
  5. * Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
  6. * Further exclusion criteria apply.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Incyte Study Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Investigative Site US257
Birmingham, Alabama, 35203
United States
Investigative Site US218
Birmingham, Alabama, 35244
United States
Investigative Site US215
Phoenix, Arizona, 85006
United States
Investigative Site US261
Phoenix, Arizona, 85037
United States
Investigative Site US221
Scottsdale, Arizona, 85255
United States
Investigative Site US262
Encino, California, 91436
United States
Investigative Site US222
Fountain Valley, California, 92708
United States
Investigative Site US211
Los Angeles, California, 90045
United States
Investigative Site US237
Los Angeles, California, 90056
United States
Investigative Site US234
Northridge, California, 91325
United States
Investigative Site US244
Castle Rock, Colorado, 80109
United States
Investigative Site US252
Farmington, Connecticut, 06030
United States
Investigative Site US208
Boca Raton, Florida, 33486
United States
Investigative Site US203
Hialeah, Florida, 33012-3618
United States
Investigative Site US258
Jacksonville, Florida, 32256
United States
Investigative Site US206
Maitland, Florida, 32751
United States
Investigative Site US223
Miami, Florida, 33136
United States
Investigative Site US202
Miami, Florida, 33173
United States
Investigative Site US247
Tampa, Florida, 33612
United States
Investigative Site US214
Tampa, Florida, 33614
United States
Investigative Site US225
Atlanta, Georgia, 30328
United States
Investigative Site US231
Columbus, Georgia, 31904
United States
Investigative Site US233
Ketchum, Idaho, 83340
United States
Investigative Site US207
Skokie, Illinois, 60077
United States
Investigative Site US205
Plainfield, Indiana, 46168
United States
Investigative Site US264
Lake Charles, Louisiana, 70601
United States
Investigative Site US236
New Orleans, Louisiana, 70012
United States
Investigative Site US326
New Orleans, Louisiana, 70112
United States
Investigative Site US266
New Orleans, Louisiana, 70115
United States
Investigative Site US254
Gambrills, Maryland, 21054
United States
Investigative Site US201
Marriottsville, Maryland, 21104
United States
Investigative Site US227
Brighton, Massachusetts, 02135
United States
Investigative Site US253
Marlborough, Massachusetts, 01752
United States
Investigative Site US268
Worcester, Massachusetts, 01655
United States
Investigative Site US238
Ann Arbor, Michigan, 48103
United States
Investigative Site US230
Auburn Hills, Michigan, 48326
United States
Investigative Site US255
Saint Peter, Minnesota, 56082
United States
Investigative Site US251
Saint Louis, Missouri, 63110
United States
Investigative Site US212
Missoula, Montana, 59804
United States
Investigative Site US216
Las Vegas, Nevada, 89148
United States
Investigative Site US235
Hoboken, New Jersey, 07030
United States
Investigative Site US217
Albuquerque, New Mexico, 87131-0001
United States
Investigative Site US219
Brooklyn, New York, 11203
United States
Investigative Site US269
Fairport, New York, 14450
United States
Investigative Site US213
Kew Gardens, New York, 11415
United States
Investigative Site US242
New York, New York, 10075
United States
Investigative Site US245
Rochester, New York, 14642
United States
Investigative Site US259
Huntersville, North Carolina, 28078
United States
Investigative Site US263
Winston-Salem, North Carolina, 27104
United States
Investigative Site US249
Columbus, Ohio, 43213
United States
Investigative Site US243
Dublin, Ohio, 43016
United States
Investigative Site US228
Mayfield Heights, Ohio, 44124
United States
Investigative Site US204
Portland, Oregon, 97201
United States
Investigative Site US226
Plymouth Meeting, Pennsylvania, 19462
United States
Investigative Site US256
Bluffton, South Carolina, 29910
United States
Investigative Site US267
Mount Pleasant, South Carolina, 29464
United States
Investigative Site US260
Cypress, Texas, 77433
United States
Investigative Site US232
Sugar Land, Texas, 77479
United States
Investigative Site US248
Arlington, Virginia, 22206
United States
Investigative Site US209
Danville, Virginia, 24541
United States
Investigative Site US229
Norfolk, Virginia, 23502
United States
Investigative Site US265
Seattle, Washington, 98105
United States
Investigative Site US224
Spokane, Washington, 99202
United States
Investigative Site US210
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Study Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11
Study Completion Date2027-07-11

Study Record Updates

Study Start Date2025-06-11
Study Completion Date2027-07-11

Terms related to this study

Keywords Provided by Researchers

  • Hidradenitis suppurativa
  • skin disease
  • ruxolitinb cream

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa